Flexible Rod Technology™ (FRT) Flexible Rod Technology provides easy bending and avoids undesirable turning on axis of the implant when erection desired by the patient.
Flexible Rod Technology™helps the rod inside reach more than 135 degrees in each bending that provides natural erection feeling.
The device is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed as having erectile dysfunction. Themalleable penile prosthesisis implanted to provide adequate penile rigidity for sexual intercourse.
It is designed for the treatment of organic, erectile dysfunction (impotence) of men due to:
• Pelvic fracture
• Spinal cord injury or disease
• Multiple sclerosis
• Diabetes mellitus,
• Arteriosclerosis and hypertensive vascular disease,
• Peyronie’s disease
• Selectively for psychogenic impotence
It is contraindicated for the patients:
• The implantation of this device is contraindicated in patients who have active urogenital infections or active skin infections in the region of the surgery.
• Whose total corporal length is less than the cylinder size.
• Sensitive to silicone materials
• Patients with neurogenic bladder and/or urinary obstruction
• Patients who are elected by the urologist as inadequate mentally or physiologically and having silicone material allergy for operation cannot be operated because of contraindications states.
• Implantation of themalleable penile prosthesisis contraindicated in patients who require repeated urethral endoscopic protocols.
• Patients who wish to retain the probability of latent, natural or spontaneous erectile ability or other interventional therapy options cannot be operated by urologist because of contraindications states.
• The implantation of themalleable penile prosthesisis contraindicated with amalleable penile prosthesisfor patients who have compromised tissue and cannot resist the permanent pressure.
• Themalleable penile prosthesisis designed to be implanted as a pair of matched cylinders. A single implanted cylinder may not be adequate to achieve sexual intercourse and may have an adverse effect on the reliability of the device.
• Known and potential complications include, but are not limited to, infection, erosion, migration, extrusion, mechanical malfunction, patient dissatisfaction, adverse tissue reaction, allergic reaction, prolonged or intractable pain, urinary obstruction, silicone particle migration, And other complications: O post-operative bleeding, hematoma, penile edema, penile necrosis/gangrene, perforation of the corpora or the urethra, inability to adequately dilate the corpora, incorrect sizing of the implant, and tearing or ripping of the device during or after implantation.
• Direct contact of surgical instruments to themalleable penile prosthesismay result in damage, rendering it unsuitable for implantation.
• During insertion, do not over bend cylinders beyond their natural U-shape as it may damage themalleable penile prosthesisand shorten its product life.
• Do not trim the distal or proximal ends of the cylinders, or the rear tip extenders. Trimming will damage the device.
• Careful intraoperative sizing is required to ensure proper device operation and to minimize the occurrence of sizing related complications such as migration and/or extrusion.
• Implantation of amalleable penile prosthesisthat has been in previous contact with or contaminated by body tissue or fluid, regardless of intervening, cleaning, or sterilization, is prohibited.
• The device is presented in a double pouch package and inside a protective carton box. The package should be checked in terms of damaging, tearing and puncture. Do not use the damaged, teared and punctured packages.
• Before unpacking, the expiry date of the product should be checked. Do not use the products which have passed the expiration date. Sterilization of the products which have passed the expiration date is not being guaranteed.
• Products which are removed from patients should be disposed as medical waste within the framework of legal procedures.
• Before operation, the urologist should decide and evaluate whether the patient is available for treatment of erectile dysfunction or not.
• A thorough preoperative consultation should include a discussion between patient and physician of all available treatment options and their risks and benefits.
• Sufficient patient skill and strength are required for the appropriate device position.
• Uncircumcised patients may have an increased risk of postoperative complications with the sub-coronal approach. Surgeons may wish to discuss performing a circumcision to reduce the risks of post-operative complications associated with this approach.
• Somemalleable penile prosthesisoperations can be complex or unpractical for patients who have penile scarring or contractor.
• Some adverse events can be occurred like urethral bleeding, pain, phimosis not high several, hematoma after operation.
• If the patient had been done revision surgery, they can live differences such length, flaccidity, sensation and girth associated with using newmalleable penile prosthesis.
• Physiology and psychology states can hinder the successful operation of the device.
Rigicon® offers the Infla10® Inflatable Penile Prosthesis (IPP) for men that need surgical intervention for the management of Erectile Dysfunction. Infla10® is indicated for patients suffering from chronic, organic erectile dysfunction (impotence) and are candidates for a penile prosthesis implantation. Refer to Infla10® three-piece Inflatable Penile Prosthesis Instructions for Use for more detailed information.
One-piece manually operated device with Large, Medium and Standard cylinder sizing options. Lubricant, instruction DVD and guide-book (ED and Peyronies). Travel bag, one year warranty when purchased privately. 100% refund option within 90 days (minus £40 handling fee).
All patient types excluding extra-wide penile diameter. Including large to narrow penile diameter, poor manual dexterity, severe venous leak, peyronies disease and hypersensitivity to ring pressure.
PeniMaster®PRO is an anatomically self-adapting connection to the glans of the penis. The device provides for physiologically proper fixation of the glans, in order to be able to elongate the penis in connection with pulling force generators. The product is suitable for men of any age with circumcised and uncircumcised penis, and matches each glans and, thus, penis size.
PeniMaster®PRO as axially symmetrical rod expander
In connection with PeniMasterPRO the rod pulling force generator allows for elongating the penis in an axially symmetrical manner without abutment far from the penis (attachment location). This means that no other bodily part or piece of clothing is required to generate the pulling force on the glans chamber and that the pulling force is nearly the same at all positions of the penis. By using the rod expander the penis can be elongated either in an upwards or a downwards direction or diagonally – and this has proven to be unobtrusive, even under normal clothing. Thus, many activities of day-to-day life can be implemented without any problems.
PeniMaster®PRO belt expander system
The belt system developed specifically for being used together with PeniMasterPRO allows for versatile training of the penis tissue by elongation. The belt pulling force generator can be worn in the most different manners, for example similar to a suspender as shoulder belt, as hip belt, or even as knee belt. Each of the techniques mentioned above has its own advantages that are described in more detail within the application. The belt expander system PeniMasterPRO can be worn unnoticeably under the normal clothing, as hip belt even under simple knickers. The belt expander system rarely and hardly limits you during your day-to-day activities, it is even possible to implement sports activities (e.g. jogging, cycling).